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April 27, 2009

Follow-on Biologics News Briefs - No. 3

Last month, Amgen Inc. Vice President Stuart Watt asserted that any follow-on biologics regulatory pathway established by Congress would have to specify an exclusivity period of at least 12 years in order to provide incentives to innovator drug companies to continue developing new biologic drugs (see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation"). On the heels of Mr. Watt's statement, Johnson & Johnson executive director for biotechnology policy Audrey Philips recently indicated that Congress should provide for a 14-year exclusivity period -- such as in H.R. 1548, introduced by Rep. Anna Eshoo (D-CA) on March 17 (see "Second Follow-on Biologics Bill Is Introduced in House").

According to a Bloomberg.com report, Ms. Philips contended that a 5-year exclusivity period -- such as in H.R. 1427, introduced by Rep. Henry Waxman (D-CA) on March 11 -- would be bad for innovation and bad for patients' health. Ms. Phillips told reporters that follow-on biologics legislation should strike "the right balance between saving money and still having medicines to advance in the future," adding that a 5-year exclusivity period would "certainly have a chilling effect on [biotech] investment." The follow-on biologics stakes are high for Johnson & Johnson as its top-selling product (arthritis drug Remicade; $3.75 billion in sales last year) and third-best-selling product (anemia drug Procrit; $2.46 billion in sales last year) are biologics.

In contrast with a number of recent announcements from other drug manufacturers (see "Follow-on Biologics News Briefs - No. 2"), Ms. Phillips stated that Johnson & Johnson had "no current plans" to get into follow-on biologics itself.

Countering Johnson & Johnson's position was Katie Huffard, executive director of the Coalition for a Competitive Pharmaceutical Market, who told Bloomberg.com that "Johnson and Johnson has less than 14 years of exclusivity in Europe where prices are controlled without innovation dying."

Lupin Moving into Biologics and Follow-on Biologics

Earlier this month, Lupin Ltd., one of India's top five pharmaceutical companies, announced plans to expand its drug research program into both biologics and follow-on biologics. According to a Business Standard report, the change in strategy was necessitated by a drying pipeline that currently includes only four drugs at the clinical trial stage. Lupin managing director Kamal Sharma stated that the company "had ambitious plans in New Chemical Entity (NCE) research but they did not translate into success," and as a result, Lupin needed to reorient its focus. With respect to its follow-on biologics program, the Business Standard noted that Lupin was developing nine drugs in the areas of oncology, auto-immune diseases, and diabetes, which were expected to be ready for launch in 2012.

Jefferson School of Population Health Dean Discusses Follow-on Biologics

Patent Docs had an opportunity to briefly discuss the topic of follow-on biologics with Dr. Nash just prior to last week's forum. Before addressing the issue of patient safety, which was the focus of the forum, we asked Dr. Nash whether he had a position with regard to the exclusivity periods provided in the two competing follow-on biologics bills currently before the House. While noting that he had no preference, Dr. Nash stated that innovator drug companies should have some measure of economic protection for a period of time. Turning to patient safety, Dr. Nash argued that Congress could ensure patient safety by passing legislation comparable to that in Western Europe, where, he noted, follow-on biologics are evaluated for safety on a case-by-case basis. Dr. Nash asserted that a generic drug manufacturer's use of an innovator drug manufacturer's data may not be sufficient to ensure patient safety, and that further review of the follow-on biologic by the FDA may be necessary.